Effectiveness of DIMS Spectacle as a Function of the Age

Luca Buzzonetti

Status: Completed

Conditions: Myopia

Treatments: Device: Defocus Incorporated Multiple Segments (DIMS)

Study type: Observational

Funder types: Other

Identifiers

NCT06556849

Myopia1

Details and patient eligibility

About

Purpose: To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients.

Methods: This was a non-randomized experimenter-masked retrospective controlled observational study of European individuals aged 6 -16 years with progressive myopia but no ocular pathology. The charts of the participants allocated to receive DIMS spectacles (Hoya® MiyoSmart®) or single vision spectacle lenses (control group) were retrospectively reviewed. The key outcome variables, cycloplegic spherical equivalent (SE) and axial length (AL), were measured at baseline and at 36 month follow up. The results were stratified by age into four groups: patients that wore DIMS spectacles oldest or youngest than 10 years (respectively, group A, 20 patients mean age 13.6±2.2 and group C, 20 patients mean age 9.0±1.2) and age matched control groups (group B, 18 patients mean age 13.2±2.5 and group D, mean age 8.5±0.9).

Full description

Participants were allocated to the study groups, receiving DIMS spectacles, or to the control groups, wearing single vision spectacle lenses.

Enrollment: 80 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient age between 6-16 years
• progressive myopia with cycloplegic spherical equivalent (SE) from -0.50 to -4.00 diopters (D)
• astigmatism less than 2.50D, anisometropia under 1.25D

Exclusion criteria

• genetic syndromes suspected (e.g., Stickler, Marfan, etc.)
• systemic diseases
• eye diseases (such as glaucoma, juvenile cataracts, retinal abnormalities, any form of strabismus)

Trial design

80 participants in 4 patient groups

Group A: patients oldest than 10 years that wear DIMS lens

Description:

myopic patients oldest than 10 years of age that wore Defocus Incorporated Multiple Segments (DIMS) spectacles

Treatment:

Device: Defocus Incorporated Multiple Segments (DIMS)

Group B: patients oldest than 10 years that wear (control group)

Description:

myopic patients oldest than 10 years of age that wore single vision spectacle lenses (control group)

Treatment:

Device: Defocus Incorporated Multiple Segments (DIMS)

Group C: patients youngest than 10 years that wear DIMS lens

Description:

myopic patients youngest than 10 years of age that wore Defocus Incorporated Multiple Segments (DIMS) spectacles

Treatment:

Device: Defocus Incorporated Multiple Segments (DIMS)

Group D: patients youngest than 10 years (control group)

Description:

myopic patients youngest than 10 years of age that wore single vision spectacle lenses (control group)

Treatment:

Device: Defocus Incorporated Multiple Segments (DIMS)